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01-12-2020 | Etanercept | Review

Assessing structural damage progression in psoriatic arthritis and its role as an outcome in research

Authors: Désirée van der Heijde, Dafna D. Gladman, Arthur Kavanaugh, Philip J. Mease

Published in: Arthritis Research & Therapy | Issue 1/2020

Abstract

Psoriatic arthritis (PsA) is an immune-mediated, clinically heterogeneous disease characterized by arthritis, enthesitis, dactylitis, spondylitis, and psoriasis of the skin and nails. Persistent articular inflammation in patients with PsA can lead to structural damage, which can result in reduced physical function and quality of life. Structural damage can occur rapidly, and irreversible joint damage may be observed if patients are not treated promptly and appropriately. Therefore, evaluating therapeutic agents for their ability to inhibit structural progression has become increasingly important, with radiographic progression becoming a key efficacy outcome in clinical trials in PsA. Here, we review how structural damage and progression are assessed in clinical trials and the use of radiographic progression as a study outcome. We also discuss possible limitations in the current assessment of radiographic progression as well as areas of research that may improve the assessment of structural damage in clinical trials of PsA.

Alinaghi F, Calov M, Kristensen LE, Gladman DD, Coates LC, Jullien D, et al. Prevalence of psoriatic arthritis in patients with psoriasis: a systematic review and meta-analysis of observational and clinical studies. J Am Acad Dermatol. 2019;80:251–65.e219.PubMedCrossRef

Coates LC, Helliwell PS. Psoriatic arthritis: state of the art review. Clin Med. 2017;17:65–70.CrossRef

Wassenberg S. Radiographic scoring methods in psoriatic arthritis. Clin Exp Rheumatol. 2015;33:S55–9.PubMed

van der Heijde D, Sharp J, Wassenberg S, Gladman DD. Psoriatic arthritis imaging: a review of scoring methods. Ann Rheum Dis. 2005;64 Suppl 2:ii61–64.

Kavanaugh A, Helliwell P, Ritchlin CT. Psoriatic arthritis and burden of disease: patient perspectives from the population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) survey. Rheumatol Ther. 2016;3:91–102.PubMedPubMedCentralCrossRef

Kerschbaumer A, Baker D, Smolen JS, Aletaha D. The effects of structural damage on functional disability in psoriatic arthritis. Ann Rheum Dis. 2017;76:2038–45.PubMedCrossRef

Kane D, Stafford L, Bresnihan B, FitzGerald O. A prospective, clinical and radiological study of early psoriatic arthritis: an early synovitis clinic experience. Rheumatology. 2003;42:1460–8.PubMedCrossRef

Haroon M, Gallagher P, Fitzgerald O. Diagnostic delay of more than 6 months contributes to poor radiographic and functional outcome in psoriatic arthritis. Ann Rheum Dis. 2015;74:1045–50.PubMedCrossRef

Gladman DD, Farewell VT, Wong K, Husted J. Mortality studies in psoriatic arthritis: results from a single outpatient center. II. Prognostic indicators for death. Arthritis Rheum. 1998;41:1103–10.PubMedCrossRef

10.

Coates LC, Kavanaugh A, Mease PJ, Soriano ER, Laura Acosta-Felquer M, Armstrong AW, et al. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis 2015 treatment recommendations for psoriatic arthritis. Arthritis Rheumatol. 2016;68:1060–71.PubMed

11.

Gossec L, Smolen JS, Ramiro S, de Wit M, Cutolo M, Dougados M, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2016;75:499–510.PubMedCrossRef

12.

Gladman DD, Chandran V. Standardizing the monitoring of outcome measures: imaging in psoriatic arthritis. Int J Clin Rheumatol. 2011;6:77–86.CrossRef

13.

Rahman P, Gladman DD, Cook RJ, Zhou Y, Young G, Salonen D. Radiological assessment in psoriatic arthritis. Br J Rheumatol. 1998;37:760–5.PubMedCrossRef

14.

Wassenberg S, Fischer-Kahle V, Herborn G, Rau R. A method to score radiographic change in psoriatic arthritis. Z Rheumatol. 2001;60:156–66.PubMedCrossRef

15.

Mease PJ, Kivitz AJ, Burch FX, Siegel EL, Cohen SB, Ory P, et al. Etanercept treatment of psoriatic arthritis: safety, efficacy, and effect on disease progression. Arthritis Rheum. 2004;50:2264–72.PubMedCrossRef

16.

Mease PJ, Kivitz AJ, Burch FX, Siegel EL, Cohen SB, Ory P, et al. Continued inhibition of radiographic progression in patients with psoriatic arthritis following 2 years of treatment with etanercept. J Rheumatol. 2006;33:712–21.PubMed

17.

Mease PJ, Gladman DD, Ritchlin CT, Ruderman EM, Steinfeld SD, Choy EH, et al. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum. 2005;52:3279–89.PubMedCrossRef

18.

Mease PJ, Ory P, Sharp JT, Ritchlin CT, Van den Bosch F, Wellborne F, et al. Adalimumab for long-term treatment of psoriatic arthritis: 2-year data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT). Ann Rheum Dis. 2009;68:702–9.PubMedCrossRef

19.

Kavanaugh A, Antoni CE, Gladman D, Wassenberg S, Zhou B, Beutler A, et al. The Infliximab Multinational Psoriatic Arthritis Controlled Trial (IMPACT): results of radiographic analyses after 1 year. Ann Rheum Dis. 2006;65:1038–43.PubMedPubMedCentralCrossRef

20.

van der Heijde D, Kavanaugh A, Gladman DD, Antoni C, Krueger GG, Guzzo C, et al. Infliximab inhibits progression of radiographic damage in patients with active psoriatic arthritis through one year of treatment: results from the induction and maintenance psoriatic arthritis clinical trial 2. Arthritis Rheum. 2007;56:2698–707.PubMedCrossRef

21.

Kavanaugh A, van der Heijde D, McInnes IB, Mease P, Krueger GG, Gladman DD, et al. Golimumab in psoriatic arthritis: one-year clinical efficacy, radiographic, and safety results from a phase III, randomized, placebo-controlled trial. Arthritis Rheum. 2012;64:2504–17.PubMedCrossRef

22.

Kavanaugh A, Husni ME, Harrison DD, Kim L, Lo KH, Leu JH, Hsia EC. Safety and efficacy of intravenous golimumab in patients with active psoriatic arthritis: results through week twenty-four of the GO-VIBRANT study. Arthritis Rheumatol. 2017;69:2151–61.PubMedPubMedCentralCrossRef

23.

van der Heijde D, Fleischmann R, Wollenhaupt J, Deodhar A, Kielar D, Woltering F, et al. Effect of different imputation approaches on the evaluation of radiographic progression in patients with psoriatic arthritis: results of the RAPID-PsA 24-week phase III double-blind randomised placebo-controlled study of certolizumab pegol. Ann Rheum Dis. 2014;73:233–7.PubMedCrossRef

24.

Mease PJ, Fleischmann R, Deodhar AA, Wollenhaupt J, Khraishi M, Kielar D, et al. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a phase 3 double-blind randomised placebo-controlled study (RAPID-PsA). Ann Rheum Dis. 2014;73:48–55.PubMedCrossRef

25.

Kavanaugh A, Ritchlin C, Rahman P, Puig L, Gottlieb AB, Li S, et al. Ustekinumab, an anti-IL-12/23 p40 monoclonal antibody, inhibits radiographic progression in patients with active psoriatic arthritis: results of an integrated analysis of radiographic data from the phase 3, multicentre, randomised, double-blind, placebo-controlled PSUMMIT-1 and PSUMMIT-2 trials. Ann Rheum Dis. 2014;73:1000–6.PubMedCrossRef

26.

van der Heijde D, Landewe RB, Mease PJ, McInnes IB, Conaghan PG, Pricop L, et al. Brief report: secukinumab provides significant and sustained inhibition of joint structural damage in a phase III study of active psoriatic arthritis. Arthritis Rheumatol. 2016;68:1914–21.PubMedPubMedCentralCrossRef

27.

Mease P, van der Heijde D, Landewé R, Mpofu S, Rahman P, Tahir H, et al. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study. Ann Rheum Dis. 2018;77:890–7.PubMed

28.

van der Heijde D, Gladman DD, Kishimoto M, Okada M, Rathmann SS, Moriarty SR, et al. Efficacy and safety of ixekizumab in patients with active psoriatic arthritis: 52-week results from a phase III study (SPIRIT-P1). J Rheumatol. 2018;45:367–77.PubMedCrossRef

29.

Mease PJ, Gottlieb AB, van der Heijde D, Fitzgerald O, Johnsen A, Nys M, et al. Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis. Ann Rheum Dis. 2017;76:1550–8.PubMedCrossRef

30.

Mease P, Hall S, Fitzgerald O, van der Heijde D, Merola JF, Avila-Zapata F, et al. Tofacitinib or adalimumab versus placebo for psoriatic arthritis. N Engl J Med. 2017;377:1537–50.PubMedCrossRef

31.

Mease PJ, Gladman DD, Collier DH, Ritchlin CT, Helliwell PS, Liu L, et al. Etanercept and methotrexate as monotherapy or in combination for psoriatic arthritis: primary results from a randomized, controlled phase III trial. Arthritis Rheumatol. 2019;71:1112–24.PubMedPubMedCentralCrossRef

32.

Mease PJ, van der Heijde D, Ritchlin CT, Okada M, Cuchacovich RS, Shuler CL, et al. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Ann Rheum Dis. 2017;76:79–87.PubMedCrossRef

33.

Tillett W, Jadon D, Shaddick G, Robinson G, Sengupta R, Korendowych E, et al. Feasibility, reliability, and sensitivity to change of four radiographic scoring methods in patients with psoriatic arthritis. Arthritis Care Res. 2014;66:311–7.CrossRef

34.

Mease PJ, McInnes IB, Kirkham B, Kavanaugh A, Rahman P, van der Heijde D, et al. Secukinumab inhibition of interleukin-17a in patients with psoriatic arthritis. N Engl J Med. 2015;373:1329–39.PubMedCrossRef

35.

Eder L, Chandran V, Gladman DD. Repair of radiographic joint damage following treatment with etanercept in psoriatic arthritis is demonstrable by 3 radiographic methods. J Rheumatol. 2011;38:1066–70.PubMedCrossRef

36.

Mease PJ, Gladman DD, Samad AS, Coates LC, Liu LXH, Aras GA, et al. Design and rationale of the Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects with Psoriatic Arthritis (SEAM-PsA). RMD Open. 2018;4(1):e000606.PubMedPubMedCentralCrossRef

37.

Mease PJ, Landewe RBM, Rahman P, Tahir H, Singhai A, Boettcher E, et al. Subcutaneous secukinumab 300 mg and 150 mg provides sustained inhibition of radiographic progression in psoriatic arthritis over 2 years: results from the phase 3 FUTURE-5 trial. Ann Rheum Dis. 2019;78:A262.

38.

Landewé R, van der Heijde D. Radiographic progression in rheumatoid arthritis. Clin Exp Rheumatol. 2005;23:S63–8.PubMed

39.

Landewe RB, Connell CA, Bradley JD, Wilkinson B, Gruben D, Strengholt S, van der Heijde D. Is radiographic progression in modern rheumatoid arthritis trials still a robust outcome? Experience from tofacitinib clinical trials. Arthritis Res Ther. 2016;18:212.PubMedCrossRef

40.

van der Heijde D, Landewe R. Should radiographic progression still be used as outcome in RA? Clin Immunol. 2018;186:79–81.PubMedCrossRef

41.

Cosentyx (secukinumab) [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; June 2018.

42.

Gladman DD, Mease PJ, Choy EH, Ritchlin CT, Perdok RJ, Sasso EH. Risk factors for radiographic progression in psoriatic arthritis: subanalysis of the randomized controlled trial ADEPT. Arthritis Res Ther. 2010;12:R113.PubMedPubMedCentralCrossRef

43.

van der Heijde D, Gladman DD, FitzGerald O, Kavanaugh A, Graham D, Wang C, Fallon L. Radiographic progression according to baseline c-reactive protein levels and other risk factors in psoriatic arthritis treated with tofacitinib or adalimumab. J Rheumatol. 2019;46:1089–96.PubMedCrossRef

44.

Ibrahim A, Gladman DD, Thavaneswaran A, Eder L, Helliwell P, Cook RJ, Chandran V. Sensitivity and specificity of radiographic scoring instruments for detecting change in axial psoriatic arthritis. Arthritis Care Res. 2017;69:1700–5.CrossRef

45.

Østergaard M, Eder L, Christiansen SN, Kaeley GS. Imaging in the diagnosis and management of peripheral psoriatic arthritis-The clinical utility of magnetic resonance imaging and ultrasonography. Best Pract Res Clin Rheumatol. 2016;30:624–37.PubMedCrossRef

46.

Ostergaard M, McQueen F, Wiell C, Bird P, Boyesen P, Ejbjerg B, et al. The OMERACT psoriatic arthritis magnetic resonance imaging scoring system (PsAMRIS): definitions of key pathologies, suggested MRI sequences, and preliminary scoring system for PsA Hands. J Rheumatol. 2009;36:1816–24.PubMedCrossRef

47.

Cimmino MA, Barbieri F, Boesen M, Paparo F, Parodi M, Kubassova O, et al. Dynamic contrast-enhanced magnetic resonance imaging of articular and extraarticular synovial structures of the hands in patients with psoriatic arthritis. J Rheumatol Suppl. 2012;89:44–8.PubMedCrossRef

Title: Assessing structural damage progression in psoriatic arthritis and its role as an outcome in research
Authors: Désirée van der Heijde
Dafna D. Gladman
Arthur Kavanaugh
Philip J. Mease
Publication date: 01-12-2020
Publisher: BioMed Central
Keywords: Etanercept
Arthritis
Psoriatic Arthritis
Published in: Arthritis Research & Therapy / Issue 1/2020
Electronic ISSN: 1478-6362
DOI: https://doi.org/10.1186/s13075-020-2103-8

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